Technical Program Manager – AI Medical Devices

🔥 0 minutes ago

🌐 United States, Canada – Remote

🇺🇸 United States – Remote 🇨🇦 Canada – Remote

💵 $170k - $200k / year

⏰ Full Time

🟡 Mid-level

🟠 Senior

🔧 Technical Program Manager

👻 Ghost score 3%

What it means: how likely this posting is sitting open without active hiring.How to read it: 60% or higher means we think this is a ghost. Lower scores are less of a worry.How we score it: age, reposts, open roles vs team size, how fast jobs close, and whether pay is listed.Fine print: an estimate from public data, not a judgment of the company. Real jobs can score high, so treat it as a hint, not a fact.

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Prenuvo

WebsiteLinkedInAll Job Openings

51 - 200 employees

🏥 Healthcare

🤖 Artificial Intelligence

🧬 Biotechnology

💰 Debt Financing on 2022-10

Healthcare • Artificial Intelligence • Biotechnology

Prenuvo is a fast growing health tech company specializing in whole body diagnostic imaging. We are a global leader in whole body MRI screening with a track record of early detection of cancer and other major health diseases. In an era of reactive and fragmented health screening, Prenuvo is rooted in early detection through cutting-edge imaging technology. Our technology brings together comprehensive scans, AI-augmented analysis, and protocols that have been honed over years of research and practice. Together, Prenuvo’s scans offer unparalleled diagnostic accuracy for you and your doctor. We empower people to make informed decisions about their health by putting comprehensive, consistent, and detailed scans in your hands. Simply put, we offer you a window into your own body. Prenuvo is one of the first scans to use artificial intelligence to build consistent, reliable, and standardized reports for the radiologists interpreting your scans. We provide faster, easier access to the clinically-significant insights needed to make more informed health decisions. We do it to help people live longer, better, healthier lives. A more comprehensive picture of your body enables you to feel empowered and advocate for yourself.

📋 Description

• Support project planning, scheduling, and progress tracking for multiple AI device programs • Collaborate with AI/ML engineers, systems engineers, regulatory affairs, product teams, and clinical operations to synchronize deliverables • Set up and maintain project documentation in Jira and other tools • Track milestones and ensure design-control and regulatory deliverables are up to date • Support readiness for regulatory submissions such as 510(k), IDE, and Health Canada submissions • Plan and execute design-control design reviews, including capturing summaries and follow-ups • Facilitate reporting and communicate project status, risks, and dependencies to program teams and stakeholders • Identify process gaps and improve collaboration, documentation flow, and delivery efficiency • Coordinate product development, model development, systems engineering, validation, quality, regulatory readiness, launch, change management, and post-market activities

🎯 Requirements

• 5+ years of experience in Technical Program Management, Technical Project Management, Engineering Program Management, medical-device product development, or a closely related discipline • 2+ years working with regulated medical devices, Software as a Medical Device, digital health, or similarly regulated clinical technology • Experience coordinating multidisciplinary technical programs from development through verification/validation and launch • Strong technical fluency and ability to work credibly with software engineers, systems engineers, AI/ML researchers, and technical product leaders • Familiarity with machine-learning development concepts such as datasets, model performance, validation, inference, deployment, and production monitoring • Working knowledge of regulated medical-device development practices, including design controls, risk management, verification and validation, change control, and post-market processes • Experience working with Quality and Regulatory teams on FDA and/or Health Canada regulated products • Applicants must be legally authorized to work in Canada or the USA at the time of hire and must not require employer sponsorship for a work visa, current or future • Familiarity with ISO 13485, ISO 14971, and IEC 62304 is strongly preferred • Experience specifically with AI/ML-enabled medical devices or SaMD is strongly preferred • Experience coordinating clinical validation or clinical-performance evaluation is a plus • Excellent program-planning, dependency-management, and risk-management skills • Exceptional communication and ability to create clarity across specialized technical disciplines • Comfort operating in a fast-moving environment where scaling processes are still being built • Successful candidates will undergo a background check in compliance with applicable federal, provincial, and state rules

🏖️ Benefits

• Positive impact on people's lives and health • Free whole-body scans for each team member • Growth opportunities and flexible career paths • Weekly team gatherings to connect, share, and socialize • Flexible vacation policy • Commuter Benefits Plan covering transit and parking costs • 401(k) retirement savings plan with pre-tax contributions; no company matching contributions • Comprehensive health, dental, vision, and Mental Health coverage